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THE (COST)EFFECTIVENESS OF NEOADJUVANT FOLFIRINOX VERSUS NEOADJUVANT GEMCITABINE BASED CHEMORADIOTHERAPY AND ADJUVANT GEMCITABINE FOR (BORDERLINE) RESECTABLE PANCREATIC CANCER (PREOPANC-2 STUDY)
EU CTIS ID: 2024-516260-29-00
What this study is testing
To determine whether neoadjuvant FOLFIRINOX followed by surgery improves overall survival and quality of life compared to neoadjuvant chemoradiotherapy followed by surgery and adjuvant gemcitabine in patients with (borderline) resectable pancreatic cancer in an intention-to-treat setting
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma)
- Written informed consent
- (Borderline) resectable tumor without metastatic disease
- WHO performance status 0 or 1
- Ability to undergo surgery, chemoradiotherapy and chemotherapy
- Leucocytes (WBC) ≥ 3.0 X 109/l
You likely can't join if
- Prior radiotherapy, chemotherapy, or resection for pancreatic cancer
- Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX
- Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer.
- Pregnancy
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator
See the full eligibility criteria
- Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma)
- Written informed consent
- (Borderline) resectable tumor without metastatic disease
- WHO performance status 0 or 1
- Ability to undergo surgery, chemoradiotherapy and chemotherapy
- Leucocytes (WBC) ≥ 3.0 X 109/l
- Platelets ≥ 100X 109 /l
- Hemoglobin ≥ 6 mmol/l
- Renal function: E-GFR > 50 ml/min
- Age ≥ 18 years
- Prior radiotherapy, chemotherapy, or resection for pancreatic cancer
- Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX
- Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer.
- Pregnancy
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.